MAUDE Adverse Event Report: TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER

Catalog Number 1BBWGQ506A2

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported an elevated white blood cell (wbc) content in the whole blood product.Donor unit #: (b)(4) there was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The device is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, d.9, h.3, h.6 and h.10.Corrected information is provided in b.6 and d.1.Investigation: we received the leukocyte reduction filters for investigation.The filters were rinsed with normal saline.The normal saline flowed relatively slow at a flow rate of 25 ml/min in (b)(6).We disassembled the rinsed filters to observe the appearance of filter media (membranes).We noticed creases in the filter media; however, the creases were not different from those observed in conforming products.We did not observe aggregates adhered to the filter media.An airtightness test was performed on each filter in accordance with the following procedures and we confirmed that air leaks were not observed in any locations of the filters.After passing normal saline through the filters, we dyed the filter media with toluidine blue for observation.We noticed that the third through sixth filter media of (b)(6) were dyed dark.That is, white blood cells were accumulated in these dyed areas.In regard to the production of the product concerned, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister trays.The top film of each blister tray is heat-sealed.For the leukoreduction filter, filter media are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.We reviewed the manufacturing record of the lot number in question and confirmed that no anomalies occurred in any process, and the product in question was manufactured as usual.In addition, we investigated dope material used for the lot number in question and found that the viscosity of pu solution of dope material conformed to the standards.Release testing, including measurements of solution concentration and volume, and a visual inspection, is performed on the product concerned as sampling testing.We therefore reviewed each testing and inspection record of the lot number in question and confirmed that there were no anomalies in all release testing items.The product conformed to the standards.Regarding the retained sample of the lot number in question, three sets were visually examined.There were no abnormalities in their appearances.We used one of the sets to measure the solution volume and used another one of the sets to perform a quantitative test for the composition of the solution in the same manner as the release testing.The measured results conformed to our in-house standards.Root cause: we control to maintain cationization levels above a certain level during the production of filter media in order to prevent from leukocyte leakage.Where a cationization level is high, filtration rate is likely to be low.For the prevention of leukocyte leakage, the instructions for use of the product state: "[caution] do not squeeze or apply pressure on the filter while it is attached to the bag containing the filtered blood", and ¿clamp the blood filled tubing before blood enters the filter¿.The above-mentioned investigation results revealed that there were no abnormalities in the manufacturing record and the testing and inspection record of the lot number concerned.The returned filters also revealed no abnormalities in themselves.We noticed that the third through sixth filter media of (b)(6) were dyed dark with toluidine blue.Therefore, occlusion may have occurred and blood may have been filtered by the filter area which was smaller than usual and the linear speed (flow rate per unit area) increased, and then leukocyte leakage occurred.

Event Description

The customer reported an elevated white blood cell (wbc) content in the whole blood product.Donor unit #: (b)(6) there was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya 418-0 004; JA 418-0004
• Manufacturer (Section G): TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP; 818 misonodaira; fujinomiya 418-0 004; JA 418-0004
• Manufacturer Contact: makoto yoshikawa ; 818 misonodaira; fujinomiya 418-0-004 ; JA 418-0004
• MDR Report Key: 14802474
• MDR Text Key: 303295786
• Report Number: 9681839-2022-00040
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2024
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 210818AG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other